CardioFocus today announced a licensing and distribution agreement with China Grand Pharmaceutical to seek regulatory approvals for the HeartLight X3 catheter ablation technology in China.
Marlborough, Mass.–based CardioFocus designed the HeartLight X3 system for controlled and consistent pulmonary vein isolation, which is the primary treatment for atrial fibrillation (AFib).
Through the agreement, Grand Pharma will pay CardioFocus up to $20 million for the rights to seek regulatory approval and to distribute and manufacture HeartLight X3 in China. CardioFocus will receive $12.5 million of the license fee as an upfront payment, with the remainder paid upon certain milestone achievements.
“Grand Pharma has an existing portfolio of medical devices and is committing to bringing our innovative HeartLight X3 System to the people of China,” CardioFocus CEO Burke Barrett said in a news release. “We look forward to immediately beginning work with the team at Grand Pharma on our first major objective: regulatory approval of X3 in China.”
HeartLight X3 uses direct tissue visualization, titratable laser energy and compliant balloon technology to treat patients with AFib who cannot control the heart condition with medication.
“CardioFocus’ HeartLight X3 addresses a need among physicians in China for a better ablation tool for PVI, one that delivers a high-quality outcome for patients as well as fast and consistent procedure times,” Grand Pharma VP Chen Xiaojie said. “We are eager to obtain regulatory approval for HeartLight X3 and bring this disruptive and revolutionary new treatment to patients.”